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ISPE News
October 2009
- ISPE Announces Availability of A-Mab Case Study at its Annual Meeting
- There’s Still Time to Submit Your Facility…and Still Time to Win!
- ISPE Adjusts Online Learning Pricing Structure to Provide Greater Value and Meet Global Economies
- FDA Issues Draft Guidance on Risk Evaluation & Mitigation Strategies
September 2009
- ISPE International Board Member Visits, Donates to Sichuan University Students
- FDA Proposes New GMP Regulation for Combination Products (79 KB PDF)
- Words to the Wise Referral Program Names Top Recruiter for 2008-2009
- PIC/S GMP Guide Revised
August 2009
- FOYA Countdown – Intent to Submit Forms Deadline is 19 October
- ISPE Welcomes Australasia Affiliate’s First Student Chapter!
- Customize your ISPE Email!
- New US FDA Leadership to Focus on “Enforcement of the Law”
July 2009
- EudraGMP 2.0 gives public access to information about Good Manufacturing Practice (GMP)
- FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting
- China's Medicine Watchdog Launches Pharmaceutical Safety Program
- Noted Food Safety Expert Michael R. Taylor Named Advisor to FDA Commissioner
- ISPE's Product Quality Lifecycle Implementation® Initiative Tours Asia!
- Annual Report of the European Medicines Agency 2008 (754 KB PDF)
- Complimentary PharmAsia News Article - Former US FDA Comm. Talks Global Collaboration
- EMEA Publishes SME Newsletter Issue 8 (496 KB PDF)
- Facts About Current Good Manufacturing Practices (cGMPs)
June 2009
- Global Regulators and ISPE Members Make for Washington Conference Success
- Free PharmAsia News for June - US Treasury Sec. Outlines Goals in US and China System Reforms
- Weidlich to Head EMEA Internal Audit Sector
- EMEA Releases Q&A on Implementing ICH Q8, Q9, and Q10 (PDF)
- US FDA Establishes Transparency Task Force
May 2009
- Hamburg Sworn In as New Commissioner of Food and Drugs
- Finland's government proposes establishing new national Medicines Agency
- Australia's TGA Publishes their Approach to Regulating PAT
- Complimentary PharmAsia News Article - Former US FDA Comm. Talks Global Collaboration
- Japan's PMDA Releases International Strategic Plan (30KB PDF)
- Australia's TGA Publishes Prescription Medicines BPI Project
- India's Central Drugs Standard Control Organization Proposes Pharma Zone for Airports, Seaports
- Free PharmAsia News Article - China Issues Healthcare Reform Plan
- MHRA Data to be Available to Medicines Regulators Across EU
- Pharma, Bio Industries to Inject $5.6 Billion for Capital & Maintenance Project Starts in Q209
- ISPE’s Sichuan University Student Chapter Takes on Glossary Translation
- New FDA Web Site Coming Soon!
April 2009
- Korea Serves Growing ISPE Membership as Latest International Affiliate
- Student Members Flock to ISPE Puerto Rico Chapter's Leadership Forum
- Free PharmAsia News Article for April - China Issues Healthcare Reform Plan
- Italy Heightens Rules for CROs
- China's SFDA Further Standardizes QC Requirements for Biologicals
- US FDA Releases Q10 Guidance Document (274 KB PDF)
March 2009
- Kenyan Pharma Industry To Grow Despite Global Conditions
- New Homeopathic Manufacturing Methods for Consultation
- EMEA Releases ICH Q10 Implementation Paper (29 KB PDF)
- Report on Implementation of the European Risk Management Strategy (PDF)
- US Lawmakers Propose Generic Biotech Drug Plan
- INTERPHEX NY Keynote Message: Industry Needs to Reinvent Itself
- EMEA Publishes 2009 Work Programme (459 KB PDF)
- Britain's MHRA Publishes Good Clinical Practice for Clinical Laboratories
February 2009
- Gain Industry-specific Knowledge at 2009 Madrid Training
- New Appointments To Health Protection Agency Board, UK
- US FDA Presentation: Writing An Effective 483 Response (PDF - 344 KB)
- Adjusted Fees for EMEA Applications Go Into Effect on 1 April
- European Commission Launches Public Consultation on GMP Guide Revision
- ISPE Offers Interactive Voice Response Live Webinar
January 2009
- Schedule Set for 2009 Student Leadership Forums
- EMEA Releases Labelling and Package Guidelines (PDF)
- 2009 Facility of the Year Award Winners Announced
- ISPE Posts 2009 Tampa Conference Seminar Agendas and Course Outlines
- FDA Lets Drugmakers Advise Doctors on Unapproved Uses
- ISPE Internet and Technology Survey
- Most health agency heads replaced before Obama
- Latest Knowledge Brief Available: Reducing the Cost of Manufacturing
- ISPE Good Practice Guide: Good Engineering Practice Now Available
- ISPE, AAPS and Reed Exhibitions Join Together to Present Life Sciences Job Fair at INTERPHEX2009
- ISPE Offers Global Network for Online Job and Candidate Searching via Career Exchange
- Become an ISPE Facebook Fan!
- Biotechnology Basics Knowledge Brief Available Online
- The FDA This Week: Andy's Take
- Annex to ICH Q8 Pharmaceutical Development Finalized
- Puerto Rico Chapter Plans Intra University Olympics
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